Zenith LifeScience · 1 month ago
QC Microbiology, Analyst I
Westborough, MA
Contract
Onsite
New Grad, Entry Level
0+ years expZenith LifeScience is focused on supporting clinical development and commercial programs through quality control microbiological testing. The Analyst I position involves performing QC testing, addressing excursions, and conducting investigations under cGMP and GLP guidelines.
Clinical TrialsConsultingLife SciencePharmaceuticalProduct Research
Responsibilities
Attire gowning for Grade B/A manufacturing areas and collect EM samples for viable air, non-viable particulates, and surface viable samples
Perform QC testing of samples for bioburden, microbial identification, growth promotion, and Endotoxin analysis
Receive manufacturing samples for QC analysis, ship samples to the contract labs testing, review data for lot disposition
Read and Review routine EM plates, lab testing data, logbooks, and documents for product release and trend reports
Understand and follow aseptic behavior, good laboratory and manufacturing practices, and documentation
Author/update laboratory procedures, protocols, and help in EM data trend reports
Support cleanroom qualification, gowning qualification, aseptic process qualification, and personnel monitoring for manufacturing activities
Initiate Incident reports for OOS results and work with the team to find a root cause and corrective actions
Perform QC lab support activities like lab set up, housekeeping, instrumentation maintenance, and coordinate instrument calibration
Qualification
Required
B.S. degree in Biology/ or other life science related degree with 0-3 years of relevant industry experience in a quality control role. While working towards a completed B.S. degree, consideration will be given to associate degree in Biology or related life sciences with 2-5 years direct industry experience
Excellent knowledge of Aseptic technique and common microbiological testing
Knowledge of relevant, compliance and guidance documents
Must be able to gown into cleanrooms in support of testing and manufacturing activities
Good documentation (ALCOA +) and data organization
Ability to work weekends is required; while most of the schedule will be during a standard work week, there will be regular weekend work
Interpersonal skills and ability to contribute to the success of a team
Preferred
Proven history of working in a fast-paced team environment, time management, and meet deadlines
Team player with the ability and willingness to support other colleagues in the Quality Control department. This support may include future cross training with analytical assays as needed
Models our Core Values: Bold, Caring, and Results-Driven — consistently exemplifies the culture we strive to create, operates with transparency, and earns trust
Company
Zenith LifeScience
Zenith LifeScience is a consulting company that specializes in clinical trials, research, pharmacovigilance, and regulatory compliance.
51-200 employees
H1B Sponsorship
Zenith LifeScience has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (21)
2024 (10)
2023 (3)
2022 (14)
2021 (4)
2020 (4)
Funding
Current Stage
Growth StageCompany data provided by crunchbase